SP Thoracic IDE Study (NCT05150210) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
SP Thoracic IDE Study
United States32 participantsStarted 2022-07-20
Plain-language summary
To confirm the safety and performance of the da Vinci SP Surgical System, Instruments and Accessories in pulmonary lobectomy, and in thymectomy procedures.
Who can participate
Age range21 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age \> 21 years
* BMI ≤ 35
* ASA ≤ 3
* Willing and able to provide a written informed consent
* Willing and able to comply with the study protocol requirements including follow-up examinations at 14 days and 30 days post-operatively, and post-market long term follow-up on an annual basis through 5 years
Lobectomy Inclusion Criteria:
\- Clinical stage I or II primary lung cancer or other suspected lung malignancy; or benign lung disease requiring resection; primary tumor ≤ 5cm diameter
Thymectomy Inclusion Criteria:
\- Masaoka clinical stage I or II thymoma; or thymectomy for myasthenia gravis; thymic mass ≤ 5 cm diameter
Exclusion Criteria:
* Clinical or radiological evidence of mediastinal or systemic metastatic disease
* Life expectancy \< 6 months
* Subject with a known bleeding or clotting disorder
* Subjects actively receiving therapeutic-dose anticoagulation or anti-platelet medications at the time of operation
* Uncontrolled systemic illness 6 months prior to planned surgical procedure including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Previous chemotherapy, immunotherapy and/or radiation therapy for treatment of the cancer to be resected
* Subject has a contraindication for general anesthesia or surgery
* Subjects under active immunomodulatory or immunosup…
What they're measuring
1
Rate of Conversion
Timeframe: Intra-operative period
2
Major Adverse Event Rate
Timeframe: Intra-operative through the 30 days follow-up period